The ULTIMO trial, investigating ultrahypofractionated versus normofractionated sequential boost after whole-breast radiation therapy in patients with Breast Cancer, reached its primary completion on 2025-11-28, having enrolled 132 participants.
Background
Breast cancer treatment often involves breast-conserving surgery followed by radiation therapy to reduce the risk of recurrence. Radiation therapy schedules, known as fractionation, can vary, with standard (normofractionated) and accelerated (hypofractionated or ultrahypofractionated) approaches. Investigating different fractionation schedules for a sequential boost after whole-breast radiation therapy is important for optimizing patient convenience, treatment efficiency, and resource utilization, while aiming to maintain similar efficacy and safety profiles. A non-inferiority design is used in trials to determine if a new treatment is not worse than an established standard treatment by more than a specified margin.
Trial design
This Phase III interventional clinical trial, identified as ULTIMO (NCT07590505), enrolled 132 participants diagnosed with Breast Cancer. The study is a monocentric, prospective, randomized controlled, open-label trial with a non-inferiority design. It compares two treatment approaches following breast-conserving surgery and standard hypofractionated whole-breast radiation therapy (WBRT). The standard treatment arm receives a normofractionated sequential boost (normSEB) of 10Gy over 5 fractions. The investigational arm receives an ultrahypofractionated sequential boost. The trial aims to assess whether the ultrahypofractionated approach is non-inferior to the standard normofractionated approach.
What this means
The primary completion of the ULTIMO trial signifies that all data collection for the study's primary endpoint has concluded for its 132 participants. This is a critical milestone, indicating that the trial is now moving into the data analysis and interpretation phase. Clinicians, researchers, and patient advocates will anticipate the publication of the results to understand if an ultrahypofractionated sequential boost is non-inferior to the standard normofractionated approach for breast cancer patients. Positive findings could potentially offer a more convenient or efficient treatment option without compromising efficacy or safety.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for NCT07590505, titled "Ultrahypofractionated Versus Normofractionated Sequential Boost After Whole-breast Radiation Therapy in Patients Treated With Breast-conserving Surgery for Breast Cancer", was updated on 2025-11-28 on clinicaltrials.gov.